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TRI Awards Four Pilot Research Studies

Kristie Hadden
Kristie Hadden
Atul Kothari
Atul Kothari
Se-Ran Jun
Se-Ran Jun
Bradley Martin
Bradley Martin

The UAMS Translational Research Institute (TRI) has approved four research pilot study awards totaling about $166,000.
Nine applicants sought awards of up to $50,000 for one-year projects that utilized translational biomedical informatics approaches to improve health and solve health care issues of rural and underserved populations.
The 2017 pilot awardees and their project titles are:

  • Kristie Hadden, Ph.D., assistant professor, College of Medicine, Division of Medical Humanities, “Patient health literacy screening: An informatics approach.”
  • Se-Ran Jun, Ph.D., assistant professor, College of Medicine, Department of Biomedical Informatics, “Genomic surveillance of mumps outbreak in Arkansas using third generation sequencing technology.”
  • Atul Kothari, M.D., assistant professor, College of Medicine, Department of Internal Medicine, “Molecular epidemiology and transmission of Clostridium difficile infections (CDI) in nosocomial settings.”
  • Bradley Martin, Ph.D., Pharm.D., professor, College of Pharmacy, “Development, validation, and implementation of an opioid risk prediction tool.”

“The purpose of our pilot awards is to help researchers develop novel technologies and methods and to test the feasibility of their approaches,” said Laura James, M.D., TRI director and associate vice chancellor for clinical and translational research. “This year’s focus on collaborations with experts in biomedical informatics will test state-of-the-art solutions to problems common in Arkansas. Each project also has high potential for extramural funding and for application to individuals beyond Arkansas.”

Applications were reviewed and scored by a study section of 23 faculty and community representatives. The study section, led by Donald Mock, M.D., Ph.D., included independent scientists from a wide range of disciplines and from across the country, and community stakeholders from across Arkansas. Inclusion of trained community stakeholders is a novel venture for this pilot program that helps realize the NIH goal of ensuring that studies have the input of the general public, clinicians and professionals in the health industry. This year was the first time that community stakeholders participated in the full review, discussion, and scoring process.

CTSA Consortium Issues Call for Inter-Institutional Pilot Award Applications

Applications Sought for CTSA Inter-institutional Pilot Awards

The Western States Consortium, which includes the UAMS Translational Research Institute (TRI) and four other Clinical and Translational Science Award (CTSA) institutions, has issued the call to all faculty for pilot award applications.

In addition to TRI, the Western States Consortium members are the University of Kentucky, University of New Mexico, University of Kansas Medical Center, and University of Utah, all part of the national CTSA consortium, supported by the National Center for Advancing Translational Sciences (NCATS) of the National Institutes of Health (NIH). (Note: The University of Kansas Medical Center is not participating in this pilot program.)

The purpose of the pilot awards is to promote inter-institutional collaboration by funding innovative, translational research projects that involve two or more of the four Western States Consortium members. Awards of up to $25,000 will be provided by each participating institution.

For additional details, view the Request for Applications (RFA) document. If you have any questions, please contact Nia Indelicato at NLIndelicato@uams.edu or 501-614-2287.

Applications are due Jan. 19, 2018, at 5 p.m., (CT). Please submit to NLIndelicato@uams.edu.

The 2017 inter-institutional RFA is the fourth pilot funding opportunity by the Western States Consortium.

Key Dates:

  • IRB Submission Deadline: Nov. 24, 2017
  • Application Deadline: Jan. 19, 2018 5:00 pm Central Time
  • Notice of intent to fund at each CTSA: Feb. 2, 2018
  • Just In Time Period: Feb. 2, 2018 – Feb. 9, 2018
  • Submission to NIH for Prior Approval of Human Subjects: Feb. 12, 2018
  • Funding Cycle: April 1, 2018 through March 31, 2019

Download Request for Applications

 

TRI Part of NIH Milestone to Accelerate Multisite Clinical Studies

CTSA Program paves way for nationwide single IRB model.

Developing new treatments for diseases often requires large numbers of clinical research participants enrolled in the same study at numerous geographical sites. These multisite clinical trials are well-positioned to discover whether a promising therapeutic is safe and effective, and may provide medical professionals with the information needed for treating their patients. However, the initiation of such studies may be delayed because each site typically relies on its own Institutional Review Boards (IRBs) to provide ethics reviews of the risks and benefits of the proposed research.

Christopher P. Austin, M.D.

The National Institutes of Health (NIH) is leading policy and programmatic initiatives to streamline this overly cumbersome process. NIH’s National Center for Advancing Translational Sciences (NCATS) announced today that all Clinical and Translational Science Awards (CTSA) Program sites (including the UAMS Translational Research Institute) have signed on to the NCATS Streamlined, Multisite, Accelerated Resources for Trials (SMART) IRB authorization agreement. This agreement — which now includes a total of more than 150 top medical research institutions — will enable all participating study sites to rely on the ethics review of one IRB for each study, making it possible to initiate multisite studies within weeks instead of months. For patients waiting to enroll in a study, this could make a life-saving difference.

The SMART IRB authorization agreement serves as a model to help investigators adhere to the NIH’s policy on single IRB use for multisite studies. This policy was designed to improve IRB efficiencies while ensuring the protection of research participants so that research can proceed expeditiously.

The authorization agreement effort was led by Harvard Catalyst, University of Wisconsin-Madison Institute for Clinical and Translational Research, and Dartmouth Synergy. Through these institutions, a team of NCATS-supported SMART IRB ambassadors facilitated and provided critical guidance and support to assist institutions in joining and implementing the SMART IRB authorization agreement.

“This milestone is a giant step toward a nationwide model for greater efficiency in IRB review, which is critical to getting more treatments to more patients more quickly,” said NCATS Director Christopher P. Austin, M.D. “It was made possible by the teamwork of hundreds of experts across the country who worked together to achieve what was thought to be impossible even a few years ago.”

In addition, the SMART IRB authorization agreement will provide the foundation for NCATS’ Trial Innovation Network central IRBs. The Trial Innovation Network is a collaborative CTSA Program initiative designed to address critical roadblocks in clinical research, and to optimize and streamline the clinical trial and studies process.

Next steps for the NCATS SMART IRB Platform include the development of education, training and harmonization of best practices for a single IRB review. Learn more at https://ncats.nih.gov/expertise/clinical/smartirb and https://smartirb.org (link is external).

About the National Center for Advancing Translational Sciences (NCATS): To get more treatments to more patients more quickly, NCATS incorporates the power of data, new technologies and strategic collaborations to develop, demonstrate and disseminate innovations in translational science. Rather than targeting a particular disease or fundamental science, NCATS focuses on what is common across all diseases and the translational process. Learn more at https://ncats.nih.gov.

About the National Institutes of Health (NIH): NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

K Awards Informational Session Recording, Slides Available

Mary Aitken, M.D., Joshua Kennedy, M.D., and Taren Swindle, Ph.D., were part of a panel discussion Thursday on NIH K awards. Kennedy and Swindle are recent K award recipients, and they shared their experiences leading to their successful applications.

Download SlidesPlay Video

UAMS Visitor Talks Latino Health Paradox and Cinco de Mayo

David E. Hayes-Bautista, Ph.D., explains the historic significance of Cinco de Mayo in the United States.

A couple of common misconceptions about Hispanics were highlighted in talks by David E. Hayes-Bautista, Ph.D., who visited UAMS and the Clinton School of Public Service last week.

Hayes-Bautista, a distinguished professor of medicine from the University of California, Los Angeles, noted that Latinos are often incorrectly lumped with other minorities when health disparities are discussed.

Like other minorities, Hispanics have the commonly cited risk factors of lower income, low education and low access to health care. And yet, for many conditions, the health of Hispanics is just as good as whites and in some cases better. For example, Hispanics in the United States have a 30 percent lower rate of heart disease – the leading cause of death – than whites.

“Whoa, lower?” Hayes-Bautista asked during a presentation to UAMS faculty. “Shouldn’t it be higher?”

The same is true for cancer, the second leading cause of death. Hispanics nationally have a nearly 40 percent lower rate of cancer deaths than whites. In Arkansas, Hispanics have a 70 percent lower death rate from cancer.

Hayes-Bautista said Hispanics/Latinos bring healthy behaviors from their native countries. For example, the smoking rate among Hispanics is about half that of whites in Arkansas.

David E. Hayes-Bautista, Ph.D., (center, back), with (l-r) TRI’s Pam Christie, Amy Jo Jenkins, Teresa Broady, Sandra Hatley, Michael Bailey, Robbie Hunt and Beatrice Boateng, Ph.D.

But those good behaviors are weakened in their U.S.-born children, who have higher rates of poor health behaviors.

For more than three decades he has studied the “Latino Epidemiological Paradox,” the tendency of Latino Americans to have health outcomes comparable to or better than their non-Hispanic white counterparts in the United States, and the implications of this paradox for populations, chronic diseases and communicable diseases.

Hayes-Bautista’s study of Hispanic culture and history led him to write the book El Cinco de Mayo: An American Tradition, a topic he presented at the Clinton School. The public event and reception was sponsored by the UAMS Translational Research Institute and the UAMS Center for Diversity Affairs, as well as the Clinton School.

Cinco de Mayo marks the Mexican military victory over the invading French army on May 5, 1862, but it’s more widely celebrated in the United States than in Mexico. The victory, he explained, prevented an alliance that would have benefited the Confederacy. Hispanics were against slavery and sided with the Union. The May 5 victory was the turning point in France’s attempt to create a monarchy over Mexico that would ally with the Confederacy. For U.S. Latinos from Mexico, the victory became a rallying cry for the Union.

In 1996, Cinco de Mayo got a U.S. postage stamp, and in 2005 it became an annual celebration in the White House and is now recognized widely across the country.

“If you ask these millions of people why are we celebrating, nobody knows. It’s just a party for some,” Hayes-Bautista said.

Billy Thomas, M.D., vice chancellor for Diversity and Inclusion at the UAMS Center for Diversity Affairs, presented David E. Hayes Bautista, Ph.D., with an Arkansas Traveler certificate following his talk at the Clinton School.

His UAMS talks are available at http://bit.ly/2nk4wMI (hosted by Peds Place) and http://bit.ly/2nPG5YW (hosted by College of Pharmacy).

His talk at the Clinton School will be available soon at: http://www.clintonschoolspeakers.com.

Hayes-Bautista is also director of the Center for the Study of Latino Health and Culture at the UCLA David Geffen School of Medicine. For the past five years, he has been chosen one of the 101 Top Leaders of the Latino Community in the U.S. by Latino Leaders Magazine. In 2012, he received the Association of American Medical Colleges Herbert W. Nickens Award for his lifelong concerns about the educational, societal and health care needs of underrepresented groups.

Hayes-Bautista has written or edited nine books on Latino health and culture and is a frequent contributor of opinion pieces to major newspapers. He has published articles in journals ranging from Academic Medicine to Salud Pública de México. He has authored dozens of proposals for funded research projects, and has given hundreds of presentations to medical and lay communities and to government agencies concerned with the nation’s health care system. Some of his center’s research on the emergence of the Latino population and society in California during the Spanish colonial, Mexican Republic, and U.S. statehood periods appears in his recent book, El Cinco de Mayo: An American Tradition (U.C. Press, 2012).

Other co-sponsors of his two-day visit were the UAMS College of Pharmacy, Arkansas Center for Health Disparities in the UAMS Fay W. Boozman College of Public Health, League of United Latin American Citizens, and the Joel E. Anderson Institute on Race and Ethnicity at the University of Arkansas at Little Rock.

Short Course on Analysis of Incomplete Data, April 28

Ofer Harel, Ph.D.

The Central Arkansas Chapter of the American Statistical Association (CASA) is sponsoring a one-day short course about the Analysis of Incomplete Data on Friday, April 28, 2017, from 9 a.m. – 4:30 p.m. in the College of Public Health building, room 8240.

Biased results and inefficient estimates are just some of the risks of incorrectly dealing with incomplete data, a common problem in applied research. This course will emphasize practical implementation of proposed strategies for dealing with missing data, including discussion of software to implement recommended procedures.

The instructor is Ofer Harel, Ph.D., professor of statistics at the University of Connecticut. Harel received his doctorate in statistics in 2003 from the Pennsylvania State University and post-doctoral training in biostatistics at the University of Washington. He has served as a biostatistical consultant nationally and internationally since 1997 and has been involved with a variety of research fields including Alzheimer’s, diabetes, nutrition, HIV/AIDS, and alcohol and drug abuse prevention.

The cost to attend the short course is $90 for CASA members, $100 for non-members, and $35 for full time students. Lunch is included in the registration fee.  See printable registration form. 

The registration fee may be paid by check with a check payable to Central Arkansas Statistical Association, credit card (send an email to James Selig jpselig@uams.edu with the completed registration form and you will receive an invoice through PayPal that can be paid with a credit card), or by IDT (email the completed registration form to jpselig@uams.edu with a note that you will be paying by IDT to Account #: 117-1003693, GL Code: 631400 and include the account to be charged).

‘Budgeting for Grant Applications’ March 24

Renee Raines, CCRP, CRA, director of the Office of Sponsored Programs Administrative Network (OSPAN), will present “Budgeting for Grant Applications” on March 24, 8:30 – 10 a.m., at the Psychiatric Research Institute, room 136.

Her presentation, part of the TRI Research and Career Development Seminar Series, will include information on OSPAN’s services provided to researchers.

Please register via TrainingTracker. The presentation is also available via BlackBoard Collaborate.  

Download Flyer

Visiting Latino Leader, Scholar to Give Three Lectures March 16, 17

UCLA Distinguished Professor of Medicine David E. Hayes-Bautista, Ph.D., who has spent decades studying and writing about the links between culture, behavior and health, will give three presentations in Little Rock on March 16 and 17.

The UAMS Translational Research Institute is sponsoring a reception following his March 16 presentation, “Latino Leadership and the Cinco de Mayo in the American West,” from 6-7 p.m., at the Clinton School of Public Service, Sturgis Hall, 1200 President Clinton Ave. 

View Flier

Hayes-Bautista is director of the Center for the Study of Latino Health and Culture at the UCLA David Geffen School of Medicine. For the past five years, he has been chosen one of the 101 Top Leaders of the Latino Community in the U.S. by Latino Leaders Magazine. In 2012, he received the Association of American Medical Colleges (AAMC) Herbert W. Nickens Award for his lifelong concerns about the educational, societal, and health care needs of underrepresented groups.

For more than three decades he has studied the “Latino Epidemiological Paradox,” the tendency of Latino Americans to have health outcomes comparable to or better than their non-Hispanic white counterparts in the U.S., and the implications of this paradox for populations, chronic diseases and communicable diseases. 

To join the March 16 lecture at ACH via live streaming on your PC, MAC, iPad or iPhone:

  1. Visit www.archildrens.org/video
  2. Click on the Peds PLACE icon
  3. Click on the topic and date listed above (or search)
  4. If watching LIVE, remember that you can send in questions for the speaker

April 12 Webinar: Learn How to Conduct Multisite Clinical Trials with a Single IRB

The first SMART IRB webinar on April 12, 3:30 – 4:30 p.m., will provide an overview of the SMART IRB Online Reliance System, which will be available to researchers later this spring. UAMS is among the Clinical and Translational Science Award (CTSA) Consortium SMART IRB participating institutions.

The Online Reliance System is a unique tool that helps institutions establish and document single IRB review arrangements. By using this system:

  • Investigators can create and submit requests to use a single IRB for their studies.
  • Collaborating institutions can work together to identify a Reviewing IRB and track and document reliance arrangements on a study-by-study basis.
  • Users have a clear understanding of next steps and are notified when action is required.

The webinar will be led by Nichelle Cobb, Ph.D., chief regulatory operations officer for Implementation for SMART IRB, and director of the Health Sciences IRBs Office at the University of Wisconsin-Madison.

Register for Webinar

 

TRI Changes Process for Study Budget Development & Negotiations

The Translational Research Institute (TRI) Clinical Trials Innovation Unit (CTIU) recently revised the process for investigators submitting studies that require a Medicare coverage analysis and budget in CLARA.  

In addition to conducting full Medicare Coverage Analysis, CTIU’s Research Finance Team (RFT) offers full budget development and/or negotiation services for all non-cancer-related protocols requiring a budget. To access all services, the investigator or designee submits a request through the TRI services portal. RFT members will work with investigators and their team to complete the budget, coverage and legal process in an efficient manner.

To increase efficiency and provide feasibility data to investigators, the RFT has altered the order of its coverage and budget activities, performing the Medicare Coverage Analysis prior to budget development and review. If investigators and their team wish to develop and/or negotiate the budget themselves, the RFT highly encourages them to submit the required study documents to the RFT prior to starting budget development. The RFT will provide a Medicare Coverage Analysis Report (MCAR) that is sent to the investigator for approval and can be used as a guide for budget development. 

It is not mandatory to obtain a MCAR prior to budget development. However, if the budget is developed prior to the MCAR it will likely delay the budget approval process for the study. If investigators or study teams have questions about this process, contact Jonathan Young, JAYoung@uams.edu, 526-7984.